Section He-P 4046.03 - Fluoroscopic X-ray Systems - Exposure Rate Limits(a) Fluoroscopic equipment manufactured on or before May 19, 1995 provided with manual mode only, shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens per minute (i.e. air kerma rate in (AKR) excess of 44 mGy per minute) at the point where the center of the useful beam enters the patient except as follows: (1) During recording of fluoroscopic images; or(2) When an optional high level control is provided, in which case the limit shall be 10 roentgens per minute (i.e. AKR 88 mGy per minute) .(b) Fluoroscopic equipment manufactured on or before May 19, 1995 provided with automatic exposure rate control with or without manual mode shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 10 roentgens per minute (i.e. AKR in excess of 88 mGy per minute) at that point where the center of the useful beam enters the patient, except during recording of fluoroscopic images.(c) Fluoroscopic equipment manufactured after May 19, 1995 provided with manual mode only, shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 5 roentgens per minute (i.e. AKR in excess of 44 mGy per minute) at the point where the center of the useful beam enters the patient.(d) Fluoroscopic equipment manufactured after May 19, 1995 provided with automatic exposure rate control with or without manual mode shall not be operable at any combination of tube potential and current which will result in an exposure rate in excess of 10 roentgens per minute (i.e. AKR in excess of 88 mGy per minute) at that point where the center of the useful beam enters the patient, except when an optional high level control which was an option at the time of purchase is provided and activated, in which case the limit shall be 20 roentgens per minute (i.e. AKR 176 mGy per minute) .(e) The exposure rate limits expressed in He-P 4046.04(c) and (d) shall not apply to: (1) Fluoroscopic equipment manufactured after May 19, 1995 but before June 10, 2006 when recording images with film or video camera with the tube in pulsed mode; and(2) Fluoroscopic equipment manufactured after June 10, 2006 when recording images from the Image Intensifier for the user after exposure termination.(f) If a high level control is provided, it shall: (1) Have a separate means of activation;(2) Be operable only when continuous manual activation is provided by the operator; and(3) Provide a continuous signal audible to the fluoroscopist when in use.(g) Any fluoroscopic equipment manufactured after May 19, 1995 which can produce an exposure rate in excess of 5 roentgens per minute (i.e. AKR in excess of 44 mGy per minute) shall be equipped with an automatic exposure rate control.(h) Compliance with He-P 4046.03 shall be determined as follows: (1) If the source is below the x-ray table, the exposure rate shall be measured one centimeter above the tabletop or cradle;(2) If the source is above the x-ray table, the exposure rate shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement;(3) For a C-arm/O-arm type of fluoroscope with fixed SID, the exposure rate shall be measured 30 centimeters from the input surface of the fluoroscopic imaging assembly, provided that the end of the beam-limiting device or spacer is no closer than 30 centimeters from the input surface of the fluoroscopic imaging assembly;(4) In a C-arm type fluoroscope having an SID less than 45 centimeters, the AKR shall be measured at the minimum SSD;(5) For a dedicated lateral type fluoroscope, the exposure rate shall be measured at a point 15 centimeters from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop, required in He-P 4046.04(g) (4) is movable, the table shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than 15 centimeters to the centerline of the x-ray table; and(6) For a special procedures type C-arm fluoroscope (angiography, interventional fluoro) with variable SID, the exposure rate shall be measured at the patient support located 30 cm from the image intensifier at minimum SID.(i) Periodic measurement of entrance exposure rate shall be performed by a qualified expert for both typical and maximum values as follows: (1) Such measurements shall be made annually or after any maintenance of the system which might affect the exposure rate;(2) Results of these measurements shall be posted in the vicinity of the control panel to allow the fluoroscopist ready access to them while using the fluoroscope;(3) Results of the measurements shall be posted in the record required in He-P 4045.05(c) ;(4) The measurement results shall be stated in roentgens per minute and include the technique factors used in determining such results;(5) The name of the person performing the measurements and the date the measurements were performed shall be included in the results;(6) Conditions of periodic measurement of typical entrance exposure rate are as follows: a. The measurement shall be made under the conditions that satisfy the requirements of He-P 4046.03(h) ;b. The kVp, mA, and/or other selectable parameters shall be adjusted to those typical of clinical use on a 23 cm thick abdomen; andc. Any x-ray system with automatic exposure rate control shall have sufficient attenuating material placed in the useful beam to produce kVp, mA, and other selectable parameters to satisfy the conditions of He-P 4046.04(i) (6) b; and(7) Conditions of periodic measurement of maximum entrance exposure rate are as follows: a. The measurement shall be made under the conditions that satisfy the requirements of He-P 4046.04(h) ;b. The kVp, mA, and other selectable parameters shall be adjusted to those settings which give the maximum entrance exposure rate; andc. Any x-ray system(s) that incorporates automatic exposure rate control shall have sufficient attenuative material placed in the useful beam to produce the maximum entrance exposure rate of the system.N.H. Admin. Code § He-P 4046.03
#6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06, EXPIRES: 2-2-07; ss by #8808, eff 1-24-07
Amended byVolume XXXV Number 06, Filed February 12, 2015, Proposed by #10763, Effective 1/23/2015, Expires7/22/2015.Amended by Volume XXXV Number 32, Filed August 13, 2015, Proposed by #10893, Effective 7/21/2015, Expires7/21/2025.